March 2009 US clinical trial update

International

Surgery or Imatinib Phase 2: Two new Phase II trials have opened for GIST at multiple locations in Japan. Both are sponsored by Niigata University Medical and Dental Hospital. There are approximately 30 sites for each trial. So we have only listed contact information for the Principal Investigator in Niigata. Together, the two trials plan to accrue over 80 GIST patients. Patients may have up to three liver metastases that are clinically judged to be surgically resectable without residual macroscopic disease, but patients with recurrence or metastases outside the liver are excluded. The studies will measure recurrence-free survival. The Principal Investigator in Niigata is: Tatsuo Kanda, MD, 81-25- 227-2228. Trial titles are: “Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor – Phase 2” and “Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor – Phase 2”

Sunitinib Phase IV: A Phase IV trial of Sunitinib, sponsored by manufacturer, Pfizer, for advanced GIST has recently opened in China. Accrual plans call for 60 patients and a primary end point of progression-free survival. Patients must have failed or be intolerant of imatinib. Three sites are recruiting, two in Beijing and one in Nanjing. The trial title is: “Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST) – Phase 4”

Masitinib Phase III: A phase III trial of Masitinib (AB1010) versus Imatinib in the first line is now recruiting internationally. The trial is sponsored by the manufacturer AB Science. This is a first-line trial for newly diagnosed GIST patients who have not received prior TKI therapy, but may have had adjuvant Imatinib. Patients must be either non-resectable or must have a recurrence after prior surgery. Patients will be randomized to receive either Masitinib 7.5 mg/kg or Imatinib 400 or 600 mg daily. Plans call for accrual of 222 patients and a primary end point of progression free survival. There are 14 sites in France, three in the United States and six in Lebanon currently recruiting. A single contact point is provided: Antoine Adenis, M.D., +33 (0)3 20 29 59 59, a-adenis@olambret. fr. The trial title is: “Efficacy and Safety of Masitinib (AB1010) in Comparison to Imatinib in Patients With Gastro-Intestinal Stromal Tumour”

United States

IPI-504 Phase III: In the United States a new site has opened for the IPI-504 Phase III trial in GIST. Recruiting has begun at St. Vincent’s Comprehensive Cancer Center in New York City. The contact is the Principal Investigator, Gerald Rosen at 212-604-6020. Contact information is also now available for the two sites in Australia. See the listing below.

To view the latest clinical trials, visit: http://www.liferaftgroup.org/treat_trials.html